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An Open-label, Randomized, Phase 2, Parallel, Dose-ranging, Multicenter Study of Sotatercept for the Treatment of Patients With Anemia and Low- or Intermediate-1 Risk Myelodysplastic Syndromes or Non-proliferative Chronic Myelomonocytic Leukemia (CMML).


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Anemia, Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), Low to Intermediate-1 MDS

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Trial Information

An Open-label, Randomized, Phase 2, Parallel, Dose-ranging, Multicenter Study of Sotatercept for the Treatment of Patients With Anemia and Low- or Intermediate-1 Risk Myelodysplastic Syndromes or Non-proliferative Chronic Myelomonocytic Leukemia (CMML).


Inclusion Criteria:



- Men and women ≥ 18 years of age

- Documented diagnosis of myelodysplastic syndromes (MDS) or non-proliferative chronic
myelomonocytic leukemia (CMML), White blood cells (WBC) ≤ 13,000 /mm3, World Health
Organization (WHO)) that meets International Prognostic Scoring System (IPSS)
criteria for low or intermediate-1 risk disease

- Anemia, Hemoglobin (Hgb) ≤ 9.0 g/dL or ≥ 2 units of Red Blood Cells (RBCs) within 84
days

- No response or loss of response to Erythropoiesis-Stimulating Agents (ESAs) or
erythropoetin (EPO) > 500 mU/ml

- Eastern Cooperative Group (ECOG) score ≤2.

- Creatinine < 1.5 X Upper Limit of the Normal (ULN)

- Total bilirubin ≤3.0 mg/dL

- Aspartate aminotransferase (AST)/Serum glutamic oxaloacetic transaminase (SGOT) &
Alanine Aminotransferase (ALT)/Serum Glutamic Pyruvic (SGPT) ≤3.0 x Upper Limit of
Norma (ULN)

- Free of metastatic malignancy (other than MDS) for ≥2 years

- Highly effective methods of birth control for females & males

Exclusion Criteria:

- Chromosome 5q deletion

- Pregnant or breast feeding women and males who do not agree to use condom during the
sexual contact with females of childbearing potential.

- Major surgery within 30 days

- Incomplete recovery or incomplete healing of wounds from previous surgery

- Heart failure ≥3 (New York Heart Association(NYHA))

- Thromboembolic or myocardial infarction event within 6 months

- Concurrent anti-cancer cytotoxic chemotherapy

- History of severe allergic or anaphylactic reaction or hypersensitivity to
recombinant protein

- Known positive for Human Immunovirus (HIV) or infectious Hepatitis type C or active
infectious Hepatitis type B.

- Clinically significant anemia unrelated to MDS

- Thrombocytopenia (<30,000/uL)

- Uncontrolled hypertension

- Treatment with another investigational drug or device within 28 days prior to Day 1

- Prior Exposure to Sotatercept (ACE-011)

- Any serious medical condition, lab abnormality or psychiatric illness

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Erythroid Hematological Improvement (HI-E)

Outcome Description:

HI-E (for subjects that require a transfusion of <4 units of RBCs) is an increase ≥1.5 g/dL Hgb sustained over a period ≥8 weeks in the absence of RBC transfusion; or HI-E (for subjects that require a transfusion of ≥4 units of RBCs) is a decrease ≥4 units of RBCs transfused over a period of 8 weeks

Outcome Time Frame:

Up to 24 weeks

Safety Issue:

Yes

Principal Investigator

Abderrahmane Laadem

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation

Authority:

United States: Food and Drug Administration

Study ID:

ACE-011-MDS-001

NCT ID:

NCT01736683

Start Date:

November 2012

Completion Date:

September 2016

Related Keywords:

  • Anemia
  • Myelodysplastic Syndromes (MDS)
  • Chronic Myelomonocytic Leukemia (CMML)
  • Low to Intermediate-1 MDS
  • ACE-011
  • anemia
  • dose-ranging
  • intermediate-1 risk myelodysplastic syndromes
  • low risk myelodysplastic syndromes (MDS)
  • multicenter
  • open-label
  • parallel
  • phase 2
  • randomized
  • Sotatercept
  • Non-proliferative chronic myelomonocytic leukemia (CMML)
  • hemoglobin
  • transfusions
  • Anemia
  • Leukemia
  • Leukemia, Myelomonocytic, Chronic
  • Myelodysplastic Syndromes
  • Preleukemia
  • Leukemia, Myelomonocytic, Acute

Name

Location

Johns Hopkins UniversityBaltimore, Maryland  21205
Cleveland Clinic FoundationCleveland, Ohio  44195
Virginia Oncology AssociatesNewport News, Virginia  23606
Rocky Mountain Cancer CentersThornton, Colorado  80260
H. Lee Moffitt Cancer CenterTampa, Florida  33612
Texas OncologyDallas, Texas  
The University of Texas, MD Anderson Cancer CenterHouston, Texas  77030
Columbia University Medical CenterNew York, New York  10032
Sarah Cannon Research InstituteNashville, Tennessee  37203
Yakima Valley Memorial Hospital/North Star LodgeYakima, Washington  98902
Dana-Farber Cancer Institute/Brigham and Women's HospitalBoston, Massachusetts  02115
North Shore-LIJ Health System Monter Cancer CenterLake Success, New York  11020